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Sponsored by: |
Technische Universität München |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00112632 |
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced gastrointestinal stromal tumor.
Condition | Intervention | Phase |
Gastrointestinal Stromal Tumor |
Drug: imatinib mesylate Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Imatinib Imatinib mesylate |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Open-Label Trial of Neoadjuvant Imatinib Mesylate (Glivec) in Patients With Locally Advanced Malignant Gastrointestinal Stromal Tumors (GIST) Expressing c-Kit or Platelet-Derived Growth Factor Receptor-Alpha |
Estimated Enrollment: | 40 |
Study Start Date: | February 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral imatinib mesylate once or twice daily for 4-6 months in the absence of disease progression or unacceptable toxicity. Within 2-3 weeks after completion of imatinib mesylate, patients with responding or stable disease undergo surgical resection.
After completion of study treatment, patients are followed at 4 weeks, 6 months, and then at 1 year.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed gastrointestinal stromal tumor
Potentially resectable disease*
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunology
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent warfarin for therapeutic anticoagulation
Austria | |||||
Allgemeines Krankenhaus - Universitatskliniken | Recruiting | ||||
Vienna, Austria, A-1090 | |||||
Contact: Johannes Zacherl 43-140-400-5622 | |||||
Germany | |||||
Dr. Horst-Schmidt-Kliniken | Recruiting | ||||
Wiesbaden, Germany, D-65199 | |||||
Contact: Norbert Frickhofen, MD 49-611-43-3009 norbert.frickhofen@hsk-wiesbaden.de | |||||
Klinikum der Universitaet Muenchen - Grosshadern Campus | Recruiting | ||||
Munich, Germany, D-81377 | |||||
Contact: Marcus Schlemmer, MD 49-89-7095-4768 | |||||
Klinikum Rechts Der Isar - Technische Universitaet Muenchen | Recruiting | ||||
Munich, Germany, D-81675 | |||||
Contact: Thomas Licht, MD 49-498-941-406-235 licht@lrz.tum.de | |||||
University Medical Center Hamburg - Eppendorf | Recruiting | ||||
Hamburg, Germany, D-20246 | |||||
Contact: Jakob R. Izbicki, MD, FACS 49-404-2803-3401 izbicki@uke.uni-hamburg.de | |||||
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch | Recruiting | ||||
Berlin, Germany, D-13122 | |||||
Contact: Peter Reichardt, MD 49-304-5055-3893 reichardt@rrk-berlin.de | |||||
Southwest German Cancer Center at Eberhard-Karls-University | Recruiting | ||||
Tuebingen, Germany, D-72076 | |||||
Contact: Joerg T. Hartmann, MD 49-707-1298-2127 joerg.hartmann@med.uni-tuebingen.de | |||||
Universitaetsklinikum Bonn | Recruiting | ||||
Bonn, Germany, D-53105 | |||||
Contact: Eva Wardelmann, MD 49-228-287-5353 eva.wardelmann@ukb.uni-bonn.de | |||||
Medizinische Universitaetsklinik I at the University of Cologne | Recruiting | ||||
Cologne, Germany, D-50924 | |||||
Contact: Clemens M. Wendtner 49-221-4788-6720 |
Technische Universität München |
Study Chair: | Thomas Licht, MD | Technische Universität München |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000430499, KRDI-TUM-GIST-CST1571-BDE43, EU-20507 |
First Received: | June 2, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00112632 |
Health Authority: | Unspecified |
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